Documents in the HRPP Toolkit Library are changed periodically in response to feedback from the community, changes in best practices for human research protections, and institutional, local, or federal regulatory changes.
See Toolkit Changes for greater detail on the changes released in March:
- Revised the Investigator Manual (HRP-103) to include additional guidance regarding reportable new information, process requirements for not human research studies and NIH GDS requests, training requirements for non-UMN employees, and resources for translation and certification services.
- Revised the Data or Specimen Only Protocol Template (HRP-595) to include clear instructions as to when to use this template and updated the Cover Page section to request information about the number of samples/data.
- Revised the Consent templates (HRP-582, HRP-592) to include a header for the witness signature block.
- Added the Standard Consent Language templates (HRP-542a, HRP-542b, HRP-542c) for external reliance submissions approved to use Quorum IRB Review, Advarra, or another external IRB.